P&P SAFETY SYRINGE

K043419 · Medexel Medical Mfg. Co., Ltd. · MEG · Apr 15, 2005 · General Hospital

Device Facts

• Record ID: K043419
• Device Name: P&P SAFETY SYRINGE
• Applicant: Medexel Medical Mfg. Co., Ltd.
• Product Code: MEG · General Hospital
• Decision Date: Apr 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries.

Device Story

The p&p Safety Syringe is a manual, single-use hypodermic syringe consisting of a calibrated hollow barrel with a Luer Lock tip and a plunger with a gasket. It is used by clinicians for intramuscular or subcutaneous injections. The device features a safety cap with a 'LOCK LINE' marking and a blue-colored adaptor. After injection, the user rotates the safety cap to the left and pushes it forward until the 'LOCK LINE' aligns with the blue adaptor, permanently locking the cap to prevent needle exposure and needlestick injuries. The device is then disposed of in a sharps container. It is compatible with general needles, allowing for gauge selection.

Clinical Evidence

Clinical investigation performed in accordance with 'Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features'. Study compared the p&p Safety Syringe to the predicate device. Results indicated the device is clinically acceptable for its intended use.

Technological Characteristics

Materials: Polypropylene (barrel/plunger), thermoplastic rubber (gasket). Luer Lock tip. Sterilization: Ethylene oxide gas (SAL 10^-6). Barrel markings conform to ISO 7886-1:1993(E). Manual operation; no software or electronic components.

Indications for Use

Indicated for intramuscular and subcutaneous medication injection in patients; aids in prevention of needlestick injuries.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• SEZ safety syringe (K031163)

Submission Summary (Full Text)

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K043419(f.1x^2)

APR 1 5 2005

510(K) Summary Medexel Medical Manufacturing Co., Ltd. 536-65 Kumkwang-Ri KumKwang-Myun, Ansung-Si, Kyunggi-Do, 456 - 862 Korea Tel : [phone]~6 Fax : [phone] Contact: J. M. Shim, Managing Director March 1, 2005

- 1) Identification of the Device: Proprietary-Trade Name: p&p Safety Syringe Classification Name: Piston Syringe Common/Usual Name: Safety Syringe
- 2) Equivalent legally marketed device: SEZ safety syringe [K031163]
- 3) Indications for Use (intended use) . This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries.
- 4) Description of the Device: The p&p Safety Syringe consists of a calibrated hollow barrel (which can contain the medication) and the distal end of the barrel has Luer Lock Tip. The needle can be changed depending on the required gauge, since the syringe is compatible with general needles. The Safety Cap can be moved back and forth as safety feature. The safety cap has a printing mark "LOCK LINE". The adaptor is colored with medical grade blue pigment . The plunger and gasket are the same shape as the conventional syringes. When user gives the intramuscular/subcutaneous injection, he/she pushes the knob of the plunger to the end. After completing the intramuscular/ subcutaneous injection, the user turns the safety cap to the left side, and then pushes it forward until the marking ("LOCK LINE") on the safety cap touches the bottom line of the blue adaptor in order to lock the safety cap and the adaptor. The blue color of the adaptor allows the user to distinguish the locking position clearly and easily. Then the safety cap can no longer be moved back and forth, thus preventing needlestick injury. Then the syringe can be disposed in the appropriate sharps container. This is a simple and elegant design which is highly reliable.

Image /page/0/Picture/7 description: The image shows two syringes. The syringe on the left has an arrow pointing up and to the right, and a curved arrow indicating rotation. The syringe on the right is in a resting position. Both syringes have needles attached.

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| Device Name | SEZ safety syringe<br>[K031163] | p&p Safety Syringe |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | This device is a Safety hypodermic<br>syringe for Intramuscular and<br>Subcutaneous injection.<br>This device aids in prevention of<br>needlestick injuries. | Identical |
| Principle operation | Activation of safety feature consists<br>of two steps :<br>1) Disassemble needle assembly<br>from the barrel by turning the<br>plunger<br>2) Retract needle into barrel and<br>confine it in the barrel by pushing<br>the plunger forward before<br>disposal. | Activation of safety feature<br>consists of the following steps :<br>1) While holding the safety<br>sheath.<br>2) Turn the flange of the barrel<br>to the right. And pull it back<br>until "LOCK LINE" touches<br>the bottom of the blue adaptor.<br>Dispose the syringe into the<br>sharps container. |
| Volume (ml/cc) | 3 | 3 |
| Nozzle type | Female conical lock fitting with<br>rotatable internally threaded neck | Male conical lock fitting (Luer Lock Tip) with rotatable internally threaded neck |
| Barrel Marking | Scale: conforms to ISO7886-<br>1:1993(E) | Identical |
| Reuse | Non-reusable | Identical |
| Biocompatibility | Conform to ISO 10993-1 | Identical |
| Materials | 1) Plastic parts : polypropylene<br>(homo type) | Identical |
| | 2) Gasket : thermoplastic rubber | Identical |
| | 3) Packing film : Medipeel film | Identical |
| | 4) Packing paper : Ethypel<br>paper | Identical |
| Sterility | Sterilized by ethylene oxide gas<br>SAL = 10-6 | Identical |

- 5) Safety and Effectiveness, comparison to predicate device:
- 6) Conclusion: In all material respects, the p&p Safety Syringe is substantially equivalent to the predicate device. The conclusion is based on biocompatibility testing, clinical testing, compliance with voluntary standards, and comparison to the predicate device. A clinical investigation was performed, and test for the comparison between p&p Safety Syringe and the legally marketed predicate device was performed in accordance with "Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA". The results of the investigation showed that the p&p Safety Syringe is clinically acceptable.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is positioned within a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

## APR 1 5 2005

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medexel Medical Manufacturing Company Limited C/O Mr. Daniel Kamm Regulatory Engineer Kamm & Associates PO Box 7007 Deerfield, Illinois 60015

Re: K043419

Trade/Device Name: p&p Safety Syringe Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: March 4, 2005 Received: March 25, 2005

Dear Mr. Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becalen between by substantially equivalent (for the referenced above and have determined and to ta legally marketed predicate devices marketed in moreations for use stated in the envioral 1, 1976, the enactment date of the Medical Device interstate commerce pror to reay 20, 1978, and essified in accordance with the provisions of Amendments, of to devices that have been reclassions approval of a prematice the premarket the Federal Food, Drug, and Cosment 1 100 ( 100 may, therefore, subject to the general approval application (1 M7Y). 1 Oa 2 ... The general controls provisions of the Act include controls provisions of the Fet. "The gential of encess, good manufacturing practice, lequirements for anitations against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (sec above) into crime and regulations affecting. (PMA), it may be subject to such additions, Title 21, Parts 800 to 898. In the Colorel your device can be found in the Code of Pederal Regalabors, 2017 device in the Federal Register.

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Page 2 - Mr. Kamm

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or mo ret or arry with all the Act's requirements, including, but not limited to: registration r ou intilet comply wart 807); labeling (21 CFR Part 801); good manufacturing practice and instille (21 - set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), r you acutact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chris L.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K043419

Device Name: p&p Safety Syringe

Indications For Use:

This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries.

Prescription Use __X__ AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

ivision Sign-Off) Civision of Anesthesiology, General Hospital, Intection Control, Dental Devices

510(k) Number: _ k 44 34 19

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